Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

West Virginia’s Supreme Court declined to expand the state’s product liability law to cover claims against branded drugs for harm caused by their generics.

The ruling responded to a 2012 lawsuit against Johnson & Johnson subsidiary Janssen Pharmaceuticals over acute respiratory distress syndrome developed by plaintiff Kimmy McNair after taking a generic of J&J’s Levaquin (levofloxacin) manufactured by Dr. Reddy’s.

The U.S. District Court in Charleston ruled that, under state law, a branded manufacturer is not liable for damages caused by a product it did not produce. On appeal, Richmond, Virginia’s 4th U.S. Circuit Court of Appeals sent the case to the West Virginia Supreme Court.

In a 3-2 decision, the Supreme Court agreed with the lower court that state law let Janssen off the hook.